Objectives
To investigate the container closure integrity of a Closed System Transfer Device syringe adaptor lock in combination with disposable Luer-Lock syringes as the terminal closure device. The UK NHS Pharmaceutical Quality Assurance committee requires syringe integrity data for final storage devices of aseptic products such as chemotherapy drugs when prepared in advance and stored prior to use as is standard practice for dose banded drugs. The assessment comprised both physical and microbial integrity testing of the combination closed system/ Luer-Lock syringes containers at syringe sizes: 1mL, 20mL, and 50mL.
Methods
Integrity testing was performed as described in the NHS Pharmaceutical Quality Assurance Committee Yellow Cover Document 2nd edition 2013 with ChemfortTM (Simplivia, IL) syringe adaptor lock devices as replacement for sterile blind hubs. Microbiological integrity was assessed according to Method 1 part 1.4 using Brevundimonas diminuta at 32oC for up to 14-days contact time. Physical integrity was assessed using Method 3 of the yellow cover document which is a dye intrusion method. Dye intrusion was assessed both visually and using a validated ultraviolet-visible spectrophotometer method.
Results
ChemfortTM syringe adaptor lock/ Luer-Lock syringe combinations were shown to be: (1) free of microbiological contamination after 14-days contact time, (2) free of dye intrusion at all syringe sizes tested (n=61 in total). The data demonstrates 100% closure integrity of the final container system when ChemfortTM syringe adaptor lock replaces the syringe hub as the terminal closure device.
Conclusions
Syringe adaptor lock components complied with the NHS Pharmaceutical Quality Assurance Committee Yellow Cover Document syringe integrity requirements when used as the terminal closure of Luer-Lock disposable syringes from 1mL up to 50mL. Therefore, syringe adaptor lock (ChemfortTM) can be used as the terminal closure system for pre-filled syringes of chemotherapeutic drug products prepared in advance in UK NHS Pharmaceutical Technical Services.
Container Closure Integrity Testing
